Rizatriptan Benzoate Odt
Generic Name: rizatriptan benzoate odt
Brand Names:
Rizatriptan Benzoate Odt
Rizatriptan benzoate orally disintegrating tablets USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is: Chemical Structure Its molecular formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.35.
Overview
Rizatriptan benzoate orally disintegrating tablets USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is: Chemical Structure Its molecular formula is C15H19N5•C7H6O2, representing a molecular weight of the free base of 269.35.
Uses
Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks. Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see CONTRAINDICATIONS (4)].
Dosage
2.1 Dosing Information in Adults The recommended starting dose of rizatriptan benzoate orally disintegrating tablets is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10 mg dose may provide a greater effect than the 5 mg dose, but may have a greater risk of adverse reactions [see CLINICAL STUDIES (14.1)]. Redosing in Adults Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose. The maximum daily dose should not exceed 30 mg in any 24-hour period. The safety of treating, on average, more than four headaches in a 30-day period has not been established.
Side Effects
The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see WARNINGS AND PRECAUTIONS (5.1)]. Arrhythmias [see WARNINGS AND PRECAUTIONS (5.2)]. Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure [see WARNINGS AND PRECAUTIONS (5.3)]. Cerebrovascular Events [see WARNINGS AND PRECAUTIONS (5.4)]. Other Vasospasm Reactions [see WARNINGS AND PRECAUTIONS (5.5)]. Medication Overuse Headache [see WARNINGS AND PRECAUTIONS (5.6)]. Serotonin Syndrome [see WARNINGS AND PRECAUTIONS (5.7)]. Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS (5.8)].
Interactions
7.1 Propranolol The dose of rizatriptan benzoate should be adjusted in propranolol-treated patients, as propranolol has been shown to increase the plasma AUC of rizatriptan by 70% [see DOSAGE AND ADMINISTRATION (2.4) and CLINICAL PHARMACOLOGY (12.3)]. 7.2 Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and rizatriptan benzoate within 24 hours is contraindicated [see CONTRAINDICATIONS (4)].
Warnings
5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina Rizatriptan benzoate should not be given to patients with ischemic or vasospastic coronary artery disease. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of rizatriptan benzoate. Some of these reactions occurred in patients without known coronary artery disease (CAD). 5-HT1 agonists, including rizatriptan benzoate may cause coronary artery vasospasm (Prinzmetal’s Angina), even in patients without a history of CAD. Rizatriptan benzoate orally disintegrating tablets are contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see WARNINGS AND PRECAUTIONS (5.1)]. Coronary artery vasospasm including Prinzmetal’s angina [see WARNINGS AND PRECAUTIONS (5.1)].
Storage
Rizatriptan Benzoate Orally Disintegrating Tablets USP, 5 mg are white to off-white colored, circular, biconvex, uncoated tablets debossed with ‘F24’ on one side and plain on other side with a peppermint flavor.
Frequently Asked Questions
What is Rizatriptan Benzoate Odt used for?▼
Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks. Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see CONTRAINDICATIONS (4)].
What are the side effects of Rizatriptan Benzoate Odt?▼
The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see WARNINGS AND PRECAUTIONS (5.1)]. Arrhythmias [see WARNINGS AND PRECAUTIONS (5.2)]. Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure [see WARNINGS AND PRECAUTIONS (5.3)]. Cerebrovascular Events [see WARNINGS AND PRECAUTIONS (5.4)]. Other Vasospasm Reactions [see WARNINGS AND PRECAUTIONS (5.5)]. Medication Overuse Headache [see WARNINGS AND PRECAUTIONS (5.6)]. Serotonin Syndrome [see WARNINGS AND PRECAUTIONS (5.7)]. Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS (5.8)].
What are the important warnings for Rizatriptan Benzoate Odt?▼
5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina Rizatriptan benzoate should not be given to patients with ischemic or vasospastic coronary artery disease. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of rizatriptan benzoate. Some of these reactions occurred in patients without known coronary artery disease (CAD). 5-HT1 agonists, including rizatriptan benzoate may cause coronary artery vasospasm (Prinzmetal’s Angina), even in patients without a history of CAD. Rizatriptan benzoate orally disintegrating tablets are contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see WARNINGS AND PRECAUTIONS (5.1)]. Coronary artery vasospasm including Prinzmetal’s angina [see WARNINGS AND PRECAUTIONS (5.1)].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.